BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 14631239 · Received June 8, 2022

    Report

    Report Number
    14631239
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 5, 2022
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NEEDLELESS CONNECTOR ON END OF PATIENT'S CENTRAL LINE BECAME BROKEN. THE SEPTUM BECAME DEPRESSED AND THEN STAYED THAT WAY WHEN DE-ACCESSED CAUSING OPEN FLUID PATH AND BLOOD BACK FLOWING OUT OF THE LINE. CONNECTOR HAD BEEN IN PLACE X 4 DAYS, SO UNABLE TO IDENTIFY LOT NUMBER. ANOTHER CONNECTOR ALSO IN USE FOR THIS PATIENT WAS FOUND WITH THE SEPTUM DEPRESSED BUT WAS ABLE TO BE MOVED BACK INTO PLACE, WAS ALSO DISCONNECTED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23819 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 12512-01 5815057

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Female